Natural History of Clostridioides Difficile Infection

Recruiting

• Conditions: Health Care Associated Infection; Nosocomial Infection; Clostridium Difficile Infection

• Registration Number: NCT04801862
• Lead Sponsor: Hospital Universitario de Valme

Brief Summary

Aim: To investigate if host factors, such as composition and diversity of intestinal microbiota and/or genetic determinants, are associated with a higher risk of recurrence of Clostridioides difficile infection (CDI). To generate a predictive tool based on epidemiological, clinical, genetic and microbiologic variables aimed to identify patients at a higher risk of CDI recurrence in a context of optimized ICD management. Design: Multicenter prospective cohort study. Patients: Older than 18 years patients with CDI diagnosis, made by IDSA criteria, in the participant centers.

Follow-up: A stewarship program aimed to improve CDI management, including early detection of CDI recurrence, will be implemented in the participant centers. Blood samples for genetic testing and stool samples for intestinal microbiome studies will be collected.

Variables and data analysis: The primary outcome variable will be the emergence of CDI recurrence. Potential independent predictors of recurrence, including genetic and microbiological factors, will be assessed. A predictive tool based on independent predictors of recurrence will be built in a development subpopulation. The performance of the model will be assessed by ROC curves, and sensititvity, especificity, as well as negative and positive predictive values will be calculated, both in the development subpopulation and in a validation subset.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-03-12
• Study First Submitted QC: 2021-03-12
• Study First Posted: 2021-03-17
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-03
• Last Update Posted: 2024-03-06
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

• Age older than 18 years
• New episode of Clostridioides difficile infection, based on IDSA criteria.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CDI recurrence	First 8 weeks after end of therapy	Clostridioides difficile recurrence
CDI reinfection	Between 8 weeks after end of therapy and before 24 weeks	New episode of Clostridioides difficile infection

Secondary Outcome Measures

Name	Time	Method
Readmission due to CDI infection	During 24 weeks after the end of therapy	New hospitalization related to new Clostridioides difficile infection episode

Trial Locations

Locations (15)

Hospital Marina Baixa; 🇪🇸 Villajoyosa, Alicante, Spain

Hospital Regional Universitario de Málaga; 🇪🇸 Málaga, Spain

Consorcio Hospital General de Valencia; 🇪🇸 Valencia, Spain

Hospital Juan Ramón Jiménez; 🇪🇸 Huelva, Spain

Hospital Universitario de Valme; 🇪🇸 Sevilla, Spain

Hospital Vega Baja; 🇪🇸 Orihuela, Alicante, Spain

Hospital General Universitario de Alicante; 🇪🇸 Alicante, Spain

Hospital Universitario San Cecilio; 🇪🇸 Granada, Spain

Hospital Universitario de Puerto Real; 🇪🇸 Puerto Real, Cadiz, Spain

Hospital Universitario Virgen de la Victoria; 🇪🇸 Málaga, Spain

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain

Hospital Universitario San Juan; 🇪🇸 Alicante, Spain

Hospital Universitario Reina Sofía; 🇪🇸 Córdoba, Spain

Hospital Politécnico Universitario La Fe de Valencia; 🇪🇸 Valencia, Spain

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, Spain